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BNT165 Malaria Vaccine

BNT165 Malaria Vaccine 2023

BioNTech SE is developing the first Messenger RNA (mRNA)-based vaccine candidate for Malaria prevention. BNT165b1 is a vaccine that expresses certain parts of the circumsporozoite protein (CSP). This vaccine candidate is based on a novel multi-antigen vaccine approach. BioNTech is evaluating a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials.

In December 2022, BioNTech initiated a Phase 1 clinical trial of BNT165b1 to evaluate the safety, tolerability, and exploratory immunogenicity of the vaccine candidate. A data update is expected in 2H 2023. The Estimated Study Completion Date is September 2024.

Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases.

BNT165 Indication

Malaria is a life-threatening disease caused by parasites transmitted to people through the bites of infected female Anopheles mosquitoes. The World Health Organization (WHO) estimated on December 8, 2022, that there were over 247 million cases of Malaria and 619,000 associated deaths in 2021. The WHO African Region was home to 95% of malaria cases and 96% of malaria deaths. Children under 5 accounted for about 80% of all malaria deaths in the Region.

BNT165 Vaccine News

December 23, 2022 - BioNTech announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. “The trial initiation is an important milestone in our efforts to help address diseases with high unmet medical need. Our objective is to develop a vaccine that can help to prevent Malaria and reduce mortality. Over the next few months, we aim to evaluate different antigens with scientific rigor to identify the optimal candidate,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech.

July 26, 2021 - BioNTech announced the launch of its Malaria project, which aims to develop a well-tolerated and highly effective Malaria vaccine and implement sustainable vaccine supply solutions on the African continent.

BNT165 Clinical Trial

Clinical trial NCT05581641 has not begun recruiting as of December 23, 2022. BioNTech’s placebo-controlled, observer-blinded Phase 1 dose escalation trial is expected to enroll approximately 60 healthy volunteers with no history of previous or current malaria infection throughout several sites in the United States. BNT165b1 will be evaluated at three dose levels.

0 min read

Manufacturer:

BioNTech

Reviewer:

Robert Carlson, MD

Vaccine:

BNT165 Malaria Vaccine

Availability:

N/A

Generic:

BNT165

Drug Class:

mRNA vaccine

Clinical Trial Phase I:

Investigational RNA-based Vaccine Against Malaria

Condition:

Malaria

Last Reviewed:

Monday, March 27, 2023 - 14:55

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

BNT163 Herpes Vaccine

BNT163 Herpes Vaccine Clinical Trials, Dosage, Indication, Side Effects

BioNTech SE's BNT163 herpes simplex virus (HSV) vaccine candidate is under development to prevent genital lesions caused by Herpes Simplex Virus-2 (HSV-2) and potentially Herpes Simplex Virus-1 (HSV-1). Based on the Company's Messenger RNA (mRNA) platform, BNT163 encodes three HSV-2 glycoproteins to help prevent HSV-2 cellular entry and spread, as well as to counteract the immunosuppressive properties of HSV-2. BNT163 is an anti-viral ribonucleic acid (RNA) vaccine candidate from BioNTech's infectious disease mRNA vaccine collaboration with the Perelman School of Medicine at the University of Pennsylvania (Penn) in Philadelphia to enter the clinic. The program is Part of BioNTech's strategy to address diseases with a high unmet medical need.

Announced on December 21, 2022, BioNTech's placebo-controlled, observer-blinded, dose-escalation Phase 1 clinical trial is expected to enroll around 308 healthy volunteers aged 18 to 55 without current or history of symptomatic genital herpes infections in the U.S. The first subject was dosed on December 21, 2022. The study comprises a first-dose escalation part, focusing on safety evaluations and assessing the optimal dose-response across various dose levels. The trial's second Part is designed to expand the safety characterization of the selected BNT163 dosing for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on safety and BNT163-induced immune responses. The ClinicalTrials.gov Identifier is NCT05432583, with an estimated study completion date of October 2026.

Currently, available HSV therapies only reduce the severity and frequency of symptoms, says the U.S. Centers for Disease Control and Prevention (CDC). As of 2025, the U.S. Food and Drug Administration (FDA) and other agencies have not authorized any herpes vaccine.

Based in Mainz, Germany, Biopharmaceutical New Technologies (BioNTech SE) (Nasdaq: BNTX) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

BNT163 Indication

HSV-1 and HSV-2 viruses cause two highly prevalent viral infections, according to the World Health Organization (WHO). Both viruses are highly contagious and can also be transmitted during childbirth. As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by hiding from the immune system in the cell bodies of neurons, where they reside lifelong and thus cannot be eradicated with current treatments. Once acquired, HSV persists lifelong in the body with recurring symptomatic outbreaks. HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth, but in some cases, it also leads to genital infections and respective lesions.

HSV-2 is a sexually transmitted disease that causes genital herpes. Therefore, infections with HSV-2 further increase the risk of acquiring and transmitting HIV infections. According to the WHO, approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2, with painful genital lesions, an increased risk for meningitis, and high levels of emotional distress. Moreover, HSV-2 infection increases the risk of acquiring HIV infection by approximately threefold. In addition, co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others, says the WHO.

BioNTech - University of Pennsylvania

In 2018, Penn and BioNTech entered into a research collaboration and license agreement to develop novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases. As a result, the Perelman School of Medicine at the University of Pennsylvania has licensed some intellectual property related to the BNT163 vaccine candidate to BioNTech. Additionally, the University receives sponsored research funding from BioNTech, associated with the preclinical development of the BNT163 vaccine candidate. As inventors of specific intellectual property related to the BNT163 vaccine candidate, some of the scientists involved in the preclinical development of the vaccine and Penn may receive additional financial benefits under the BioNTech license in the future. The Penn (BNT163-01) research study is being conducted to determine the optimal dose of the investigational vaccine, BNT163, and to assess its safety and tolerability.

BNT163 Herpes Vaccine News

February 23, 2023 - Herpes Vaccines Focus on mRNA.

December 21, 2022 - "This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies, such as mRNA, and our expertise in immune engineering," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech, in a press release. "BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. We aim to induce a broad immune response against multiple antivirus antigens and mobilize various immune effectors to support virus neutralization and clearance."

November 5, 2018 - BioNTech AG, a rapidly growing biotechnology company focused on the development of immunotherapies for the precise and individualized treatment of cancer and prevention of infectious diseases, and the University of Pennsylvania (Penn), Philadelphia, USA, today announced that they have entered into a strategic research collaboration. The exclusive, multi-year partnership aims to develop novel nucleoside-modified mRNA vaccine candidates for the prevention and treatment of various infectious diseases.

BNT163 Herpes Vaccine Clinical Trials

Phase 1 study: ClinicalTrials.gov Identifier: NCT05432583 - This exploratory trial will have two parts. While Part A will focus on safety evaluations, vaccine-induced immune responses, specifically neutralizing antibodies, will also be analyzed to assess whether there is a dose-response relationship. The trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A.

0 min read

Manufacturer:

BioNTech SE

Reviewer:

Robert Carlson, MD

Vaccine:

BNT163 Herpes Vaccine

Availability:

N/A

Generic:

BNT163

Drug Class:

mRNA vaccine

Clinical Trial Phase I:

Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions

Condition:

Herpes

Last Reviewed:

Friday, December 12, 2025 - 09:55

Status:

Candidate

Manufacturer Country ID:

Location tags:

United States of America

Germany

Dukoral Cholera Vaccine

DUKORAL® Cholera Vaccine Clinical Trials, Dosage, Indication, Side Effects

Valneva SE's DUKORAL® is an oral, inactivated vaccine for preventing diarrhea caused by Vibrio cholerae and/or heat-labile toxin-producing enterotoxigenic Escherichia coli (ETEC). Since the 1980s, either killed or live oral cholera vaccines (OCVs) have been developed, and efficacy and effectiveness studies have been conducted. DUKORAL contains four different inactivated strains (types) of V. cholerae serotype O1 and part of a toxin from one of these strains as active ingredients, according to the European Medicines Agency (EMA). Dukoral is a vaccine administered orally to protect individuals against cholera. DUKORAL suspension and effervescent granules for oral suspension. DUKORAL's ATC code: J07AE01, J07AE02, J07AE51.

The World Health Organization (WHO) has prequalified the DUKORAL vaccine. It is authorized in Europe, Australia, Canada, Ireland, Mayotte, New Zealand, Switzerland, Thailand, and the United Kingdom to protect people against cholera and Enterotoxigenic Escherichia coli (ETEC). The EMA (EMEA/H/C/000476) states that Dukoral is used in individuals aged 2 years who will be visiting areas with a high risk of cholera. The WHO announced on February 12, 2024, that global demand for OCVs (74 million) has exceeded supply (38 million). Valneva announced on November 7, 2024, that DUKORAL sales in the third quarter of 2024 increased by 85% year-over-year, as marketing investments resumed following a successful regulatory inspection of the Company's new manufacturing site in Sweden.

France-based Valneva SE's strategy is rooted in its vision of contributing to a world where no one dies or suffers from a vaccine-preventable disease. Dukoral initially produced the SBL vaccine.

DUKORAL Cholera Vaccine Indication

The U.S. CDC recommends vaccination for people traveling to or living in areas of active cholera transmission. In addition, active immunization against disease caused by Vibrio cholerae serogroup O1 is recommended for adults and children (2 years and older) who will be visiting endemic/epidemic areas. But cholera vaccines are not 100% effective. Check the CDC's Travel Health Notices to identify areas with active cholera transmission.

DUKORAL Cholera Vaccine Dosage

DUKORAL is administered orally with a buffer solution that requires 150 ml of clean water for adults. The standard primary course for adults and children over six years old consists of two doses; children under six years old should receive three doses. Doses are to be administered at intervals of at least one week but less than six weeks apart. The primary immunization course should be restarted if more than six weeks have elapsed since the last dose. Immunization should be completed at least one week before potential exposure to Vibrio cholerae O1.

Each dose of DUKORAL vaccine suspension (3ml) contains a total of 1.25 x 1011 bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25 x 109 bacteria, Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x 109 bacteria—recombinant cholera toxin B subunit (rCTB) 1mg.

DUKORAL Vaccine Production

Valneva's global manufacturing network comprises three in-house operations, covering both internal and external production of clinical and commercial products. Valneva's U.S. FDA-approved manufacturing site in Livingston, located just outside Edinburgh, is currently dedicated to producing drug substances for our viral vaccines. Valneva's manufacturing site in Solna is just outside of Stockholm. The site has a long history of vaccine manufacturing and is affiliated with Sweden's state-owned vaccine institute. Valneva's new manufacturing site in Sweden underwent regulatory evaluation and approval in 2024. Along with Valneva's development center in Vienna (Austria), the Company operates GMP laboratories and facilities for the testing and quality control of Valneva's commercial and clinical-stage vaccines.

DUKORAL Cholera Vaccine Warnings and Precautions

DUKORAL® confers protection specific to Vibrio cholerae serogroup O1. Immunization does not protect against V. cholerae serogroup O139 or other species of Vibrio. Administration of DUKORAL® should be postponed for subjects suffering from acute gastrointestinal or febrile illness. DUKORAL is not recommended for use in children under two years of age. Formaldehyde is used during manufacturing, and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. DUKORAL contains approximately 1.1 g of sodium per dose, which patients should consider when following a controlled sodium diet. The vaccine does not provide complete protection against the disease.

Cholera Outbreaks

Various countries have reported cholera outbreaks in 2025.

DUKORAL Vaccine News

August 12, 2025 - In the first half of 2025, DUKORAL® sales were €17.4 million compared to €14.9 million in the first half of 2024. The supply of doses notably contributed to this 16.4% growth, supporting efforts to combat an outbreak on the French island of Mayotte, for a total of €1.1 million in the first quarter of 2025.

May 7, 2025 - Valneva SE reported that in the first quarter of 2025, DUKORAL sales increased 9.4% to €12.3 million, primarily driven by the supply of doses to the French Department of Mayotte.

December 18, 2024—The WHO reported that Oral Cholera vaccine production reached its highest level in November since 2013. This increase allowed the average stock to rise to 3.5 million doses in November, compared to 600,000 in October 2024.

March 20, 2024 - The Company confirmed that DUKORAL® vaccine sales benefited from the significant recovery in the private travel markets.

September 30, 2022 - Cholera Vaccine: Recommendations of the U.S. CDC Advisory Committee on Immunization Practices.

DUKORAL Clinical Studies

In September 2023, a Research Article focused on cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries.

Challenge studies in human volunteers provided the first demonstration of efficacy. The challenge study at the University of Maryland enrolled healthy participants aged 19 to 35. Participants receiving either WC-BS (with 5 mg of CTB) or WC were given three doses at 2-week intervals. In addition, Cimetidine was administered three hours before receiving the vaccine, along with the sodium bicarbonate solution mixed with the vaccine. Vaccinated participants and unvaccinated controls were challenged with 2 × 106 El Tor Inaba V. cholerae (strain N16961) four weeks after completion of the third dose of WC (n = 9) and five weeks after completion of WC-BS (n = 11). The vaccine efficacy of WC was found to be 56%, and for WC-BS, 64% (Table 2). Vaccinated participants in both groups who developed cholera had less severe illness than controls and complete protection from severe diarrhea.

The EMA states that the Company presented data from the published literature and the results of three central studies involving nearly 113,000 people to support the use of Dukoral. In all three studies, Dukoral, given in either two or three doses, was compared with a placebo (a dummy vaccine). The studies took place in areas where cholera was found. The primary measure of effectiveness was the 'protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and a placebo.

The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with a placebo. In this study, Dukoral was formulated using the cholera toxin extracted from cholera bacteria, rather than the newer recombinant toxin. The protective effectiveness of Dukoral was 85% over a six-month period. Protection lasted for six months in children and two years in adults. In adults, two doses of the vaccine were as effective as 3.

The other two studies compared Dukoral (containing recombinant cholera toxin) with a placebo in over 22,000 people in Peru. In the first of two doses, Dukoral's protective effectiveness was 85% for the first five months after vaccination. The people in the second study also received a booster dose 10 to 12 months later. The protective effectiveness of Dukoral after the booster dose was 61% during the second year of follow-up.

0 min read

Manufacturer:

Valneva SE

Reviewer:

Robert Carlson, MD

Vaccine:

Dukoral Cholera Vaccine

VIS:

PDF

Availability:

Australia, Canada, New Zealand, Europe, France, New Zealand, United Kingdom, and Thailand

Generic:

Cholera Vaccine

Drug Class:

Vaccine

Find Price:

Discounts

Clinical Trial Phase II:

Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine

Clinical Trial Phase III:

Oral Cholera Vaccine Efficacy and Effectiveness

Condition:

Cholera

Availability Link:

Europe

Last Reviewed:

Monday, September 15, 2025 - 07:35

Brand:

DUKORAL®

ChEMBL ID:

07AE01

Accession Number:

J07AE01

Status:

Approved

Manufacturer Country ID:

Side Effects:

Ingredients:

Countries:

Location tags:

United States of America

Cholera Outbreaks

Cholera Outbreaks September 2025

The World Health Organization (WHO) has recorded seven cholera pandemics over the past two centuries. The current (7th) cholera epidemic is considered to have started in 1961. As of September 2025, over 409,222 cholera/Acute Watery Diarrhoea cases and 4,738 deaths were reported globally, from 31 countries, with six of the 31 countries reporting case fatality rates above 1%. The WHO's Global Cholera and Acute Watery Diarrhoea Dashboard was updated in 2025. In 2024, 804,721 cholera cases and 5,805 related fatalities were reported from 33 countries. Data show that 472,697 cholera cases were reported to the WHO in 2022, up from 223,370 in 2021.

The U.S. Centers for Disease Control and Prevention (CDC) has identified an unprecedented global increase in cholera outbreaks over the last four years: 2022, 2023, 2024, and 2025. In addition, the Pan American Health Organization (PAHO) and the European CDC, and the WHO have reported active cholera transmissions in Angola, Benin, Cameroon, the Democratic Republic of the Congo, Eswatini, Ethiopia, India, Haiti, Kenya, Malawi, Mozambique, Myanmar, Nepal, Niger, Nigeria, Somalia, South Africa, South Sudan, Tanzania, Uganda, and Zambia, and Syria.

Cholera Cases in the U.S.

With modern water systems, there are now typically fewer than 20 cholera cases a year. Nearly all cholera cases reported in the U.S. are acquired during international travel. As of May 2025, there were (1) cholera cases reported in the U.S. As of December 31, 20224, week #52, eight cholera cases were reported to the CDC this year. In 2023, there were 17 cases, and in 2022, the CDC confirmed that eight travelers infected with cholera arrived from Pakistan, Iraq, and Bangladesh. Additionally, the CDC's Clinician Outreach and Communication Alert in 2023 reported an unprecedented global increase in cholera infections.

Cholera Vaccines

As of September 2025, various cholera vaccines have been approved by the WHO but remain in limited availability globally.

2 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Monday, September 15, 2025 - 12:20

Description:

Cholera is a vaccine preventable disease causing outbreaks in 2025

Condition:

Cholera

Measles Outbreaks

Measles Outbreaks 2025

The World Health Organization (WHO) reported that measles outbreaks continued in 2025, as 184 WHO Member States reported measles cases. As of May 28, 2025, the U.S. Centers for Disease Control and Prevention (CDC) maintains a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice, identifying measles outbreaks in over 50 countries, which include Afghanistan, Angola, Armenia, Azerbaijan, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Côte d'Ivoire (Ivory Coast), the Democratic Republic of the Congo, Djibouti, Equatorial Guinea, Ethiopia, Gabon, Ghana, India, Indonesia, Kazakhstan, Kazakhstan, Kyrgyzstan, Lebanon, Liberia, Libya, Malaysia, Mauritania, Nepal, Niger, Nigeria, Pakistan, Philippines, Qatar, Republic of South Sudan, Republic of the Congo, Romania, Russia, Senegal, Somalia, Sri Lanka, Sudan, Syria, Tajikistan, Timor-Leste, Togo, Turkey, United Arab Emirates, Uzbekistan, Yemen, and Zambia.

United States Measles Outbreaks 2025

As of December 10, 2025, the CDC reported more than 1,900 confirmed measles cases across 43 US jurisdictions. The CDC issued a Health Alert Network (CDCHAN-00522) on March 7, 2025, regarding measles outbreaks in western Texas. The Texas Department of State Health Services (DSHS) submitted 92 identical DNA sequences in genotype D8, while 10 DNA sequences from New Mexico and one from Kansas were similar to those from Texas. Additionally, five distinct genotype B3 sequences were reported from the States of Alaska, California, Florida, Kentucky, New York, Rhode Island, Texas, and Washington. The Annual Report on Immunization Status of Texas Students for the 2023-2024 School Year indicates a high statewide vaccination rate of over 94%.

United States Measles Outbreaks 2024

As of December 31, 2024, the US CDC reported 285 measles cases (49 imported) in 33 jurisdictions: Arizona, California (San Diego, Los Angeles), Florida (Broward, 10), Georgia, Idaho, Illinois (Chicago (67)), Indiana, Louisiana, Maryland, Michigan, Minnesota (70), Kansas City, Missouri, New Jersey (Camden, Monmouth, Somerset counties), New York (New York City (13)), Nevada, North Carolina, Ohio (Cincinnati), Oregon (31), Pennsylvania (Philadelphia), Tennessee, Virginia, Washington, Washington DC, West Virginia, and Wisconsin. About 56% of cases were hospitalized for management of measles complications, and 39% were under five years of age. As of 2024, there are no CDC recommendations for receiving a third MMR dose during measles outbreaks.

United States Measles Outbreaks 2023

The US CDC reported 59 measles cases in 20 jurisdictions across the United States in 2023. The majority of these cases involved unvaccinated international travelers in California, Colorado, the District of Columbia, Florida, Hawaii, Idaho, Illinois, Kentucky, Maryland, Missouri, New Jersey, New York City, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.

United States Measles Outbreaks 2022

According to the CDC, there were 121 measles cases in the US in 2022. Between 2000 and 2022, there was an 18% increase in estimated measles cases and a 43% increase in estimated measles deaths compared with 2021. The Health Department of the City of Columbus, Ohio, and Franklin County Public Health (FCPH) reported 85 confirmed measles cases in children, with 80 of the cases being unvaccinated and 36 resulting in hospitalization.

Measles Outbreak Costs

In April 2021, the journal Pediatrics published a study indicating that treatment costs were $47,479 per hospitalized case during a measles outbreak. In January 2020, Clinical Infectious Diseases published a meta-analysis estimating the median price per hospitalized measles case at $32,805.

Measles Testing

After MMR vaccination, syndromic panels can detect the measles vaccine virus, which is not transmitted to others and does not cause disease in immunocompetent persons. The US CDC reported in March 2024 that among syndromic test panels conducted by a commercial laboratory, approximately 1% were positive for measles. Patients who received these results were children without known measles risk factors who had been vaccinated against measles; the majority <3 Weeks previously. Their results were attributed to the detection of the measles vaccine virus.

Measles Vaccines

During a measles outbreak, the US CDC's Advisory Committee on Immunization Practices (ACIP) outlines cases for administering a third MMR dose.

4 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Thursday, December 11, 2025 - 13:55

Description:

Measles detected in Africa, Australia, Brazil, Canada, Caribbean, England, Europe, India, Indonesia, and United States.

Condition:

Measles

West Nile Virus Vaccines

West Nile Virus Vaccine Candidates 2025

The US Food and Drug Administration (FDA) has not approved West Nile virus (WNV) vaccines for use in humans as of December 2025. However, active human clinical studies include vaccine candidates: two live attenuated chimeric vaccines, one DNA vaccine, one recombinant subunit vaccine, and two inactivated whole-virus vaccines. A Research Article published in October 2025 stated that live-attenuated vaccines, including flavivirus YFV 17D and JEV SA14-14-2 vaccines, offer the advantages of robust immune responses and long-lasting protection.

In Phase 2 trials, the live attenuated recombinant yellow fever vaccine strain expressing the premembrane and envelope (prM–E) genes of WNV (ChimeriVax-WN02, Sanofi Pasteur) demonstrated a favorable safety profile and immunogenicity, even in older age groups, following a single dose.

The HydroVax-001 vaccine candidate consists of a hydrogen peroxide-inactivated whole virion (WNV-Kunjin strain) adjuvanted with aluminum hydroxide.

"Our experience over the past two decades has demonstrated that current prevention strategies are insufficient to reduce the ongoing WNV disease burden. WNV vaccination would be more effective in preventing WNV disease and related deaths," wrote a Perspective published by the NEJM on May 4, 2023. "The benefits of live vaccines, including durability of immunity and the need for only one dose, will need to be weighed against potential safety concerns."

2 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Wednesday, December 17, 2025 - 15:40

Description:

West nile virus vaccine candidates are conducting clinical trials

Condition:

West Nile Virus

Dengue Outbreaks

Dengue Outbreaks September 2025

According to the World Health Organization (WHO) and numerous health agencies, Dengue is a viral infection spread to humans by infected mosquitoes of the Aedes genus and a leading cause of febrile illness among international travelers in 2025. The WHO has classified Dengue as a grade 3 emergency, with an estimated 4 billion people at risk globally. The WHO states that Dengue is a vaccine-preventable disease, endemic in approximately 110 countries, including areas within the United States, such as Florida and Puerto Rico.

As of August 21, 2025, the WHO Dengue Situation Update 728 indicates that over 6 million Dengue cases and 7,552 related fatalities have occurred in 2025. More than 13 million dengue cases were reported in 2024, marking the highest number of cases on record.

On January 20, 2025, the WHO published a Global Strategic Preparedness, Readiness, and Response Plan for Dengue. Dengue's four subviruses are usually spread to people through the bites of infected Aedes mosquitoes. On October 3, 2024, the WHO launched the Global Strategic Preparedness, Readiness, and Response Plan to tackle Dengue and other Aedes-borne arboviruses. The WHO plan aligns with the Global Vector Control Response 2017-2030, a global strategy to strengthen vector control worldwide, and the Global Arbovirus Initiative.

An analysis published in July 2024 reported that the most frequent regions of dengue infection acquisition were Southeast Asia (50.4%), South Central Asia (14.9%), the Caribbean (10.9%), and South America (9.2%). The median age was 33 years, and tourism was the most frequent reason for travel (67.3%). An analysis published in December 2024 revealed a clear link between climate change and the expansion of vectors, such as mosquitoes, into new territories, increasing disease incidence. Mosquitoes that spread Dengue viruses usually live below 6,500 feet; therefore, a person's chances of getting Dengue in high altitudes are very low.

Dengue Outbreak Travel Advisories

The U.S. Centers for Disease Control and Prevention (CDC) reissued a Global Travel Health Notice on August 21, 2025, regarding Dengue outbreaks in the Americas, Africa/Middle Eas t, and Asia/Pacific regions, such as India, Singapore, Thailand, the Philippines, Malaysia, and Myanmar. The CDC has not issued travel advisories for U.S. states that have reported local dengue outbreaks, such as Florida and Puerto Rico. As of August 2025, HealthMap has published dengue case maps.

Dengue Outbreak in the United States

As of July 2025, the U.S. CDC advises clinicians to consider Dengue in patients with fever who live in or have recently traveled to areas with a risk of Dengue. The CDC reported in September 2025 that 3,045 Dengue cases occurred in 47 jurisdictions this year. The CDC says transmission of Dengue virus serotypes (DENV-1, 2, 3, 4) remains high in the U.S. territories of Puerto Rico and the U.S. Virgin Islands. DENV-3 is the most common (84%) serotype identified in 2025.

In 2024, 53 jurisdictions, led by Arizona, California, Florida, New Jersey, New York, and Puerto Rico, reported 9,391 dengue cases. In June 2024, the CDC issued an updated Health Alert Network Health Advisory, notifying healthcare providers, public health authorities, and the general public of an increased risk of dengue virus infections in the United States. In 2023, 52 U.S. jurisdictions reported 6,164 dengue cases to the CDC.

As of December 2024, the Florida Department of Health (FDH) reported over 999 travel-associated and 91 locally acquired dengue cases throughout the state, with the majority occurring in Miami-Dade County.

The Texas Department of State Health Services (DSHS) reports that mosquitoes that transmit dengue fever are present in the state of Texas. As of September 2025, DSHS reported 31 travel-related dengue cases this year. As of December 2024, there were 43 imported dengue cases in 23 Texas counties, led by Travis County (18), and one local case in Cameron County, with one related fatality. Texas reported 79 travel-related dengue cases in 2023 and one locally acquired case in Val Verde County.

In California, the San Bernardino County Public Health Department reported (1) a locally acquired case of Dengue in San Bernardino on November 7, 2024. The Los Angeles County Department of Public Health has reported 12 locally acquired dengue cases in the San Gabriel Valley , specifically in the cities of Baldwin Park (8), El Monte (2), Hollywood Hills (1), and Panorama City (1), in 2024. Dengue cases were reported in San Diego, Escondido, and Vista in 2024. Over 360 dengue cases were confirmed in California in 2023. California reported two locally acquired cases (in Long Beach and Pasadena) and 250 travel-related cases.

Between 2010 and 2023, 250 locally acquired cases were reported in Hawaiʻi.

Dengue Outbreak U.S. Territories

The CDC says the Dengue virus is endemic in the U.S. territories of Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. On July 7, 2025, American Samoa declared a public health emergency due to a surge in dengue cases. In the U.S. Virgin Islands, a dengue outbreak was declared in August 2024 and remains in effect in 2025. A total of 208 locally acquired cases were identified in 2024 and 30 in 2025, all on the island of St. Croix. The Virgin Islands Department of Health urged residents to take immediate precautions to prevent further dengue transmission as cases surged in the St. Thomas-St. John's area. John's area. John's area. John's area. John's area. John's area. John's area. John's area. John's area. John's area. John and St. Croix Districts.

In March 2024, the Health Ministry declared a public health emergency in Puerto Rico, which remains in effect as of 2025. As of March 7, 2025, 936 cases have been reported, representing a 113% increase compared to the same period in 2024. In 2024, 6,291 cases were reported, and 13 deaths were reported. Puerto Rico's Department of Health confirmed that Dengue was endemic in the greater San Juan area, with 4,467 cases.

Among American Samoa school-aged children, the estimated seroprevalence was 59% for those aged 7–16.

Dengue Outbreaks in Africa

Dengue circulation has been detected in more than 30 African countries. According to the Africa CDC Epidemic Intelligence Report, as of January 2025, over 1,300 dengue cases have been reported in Africa. As of 2024, over 74,000 dengue cases have been reported this year from Burkina Faso, Cameroon, Cabo Verde, Central African Republic, Chad, Côte d'Ivoire, Ethiopia, Ghana, Kenya, Mali, Mauritius, São Tomé and Príncipe, Senegal, Sudan, and Togo. The ACDC reported in 2024 that travelers visiting these African countries may be at an increased risk of Dengue. In 2023, 171,991 dengue cases and 753 deaths were reported in African countries.  The U.S. CDC issued a Travel Health Notice in 2023, confirming Dengue is an ongoing risk in Africa. A December 2025 study found that countries in eastern Africa had a high estimated risk of dengue importation from Asia and other countries in east Africa. In contrast, for West African countries, the risk of importation was higher from within the region than from countries outside of Africa.

Dengue Outbreaks in the Americas

The first suspected dengue-like epidemics were reported in 1635 in Martinique and Guadeloupe. The Pan American Health Organization (PAHO) issued an Epidemiological Alert in February 2025, based on the growing circulation of DENV-3, which had not been circulating previously, thereby increasing the probability of severe cases. In epidemiological week 34 of 2025, a total of 3,740,133 suspected dengue cases were reported. This data represents a 68% decrease compared to the same period in 2024. As of December 31, 2024, 49 countries and territories in the Americas reported over 13,017,982 Dengue cases and 8,151 related deaths in 2024. In 2023, 4,617,108 Dengue cases were reported in the Americas.

Argentina's Epidemiological Bulletin reported over 580,000 dengue cases in 2024, with 56,435 in Buenos Aires. Argentina's Ministry of Health published a Comprehensive Preparedness and Response Plan for Dengue Epidemics 2024-2025.

Over the past 25 years, nearly 18 million Brazilians have contracted one of the four viruses that cause Dengue. Brazil's Ministry of Health reports indicate that, as of 2024, there were over 9.6 million dengue cases and 5,441 related deaths. The São Paulo state dengue data dashboard was updated in May 2025. A study published in The Lancet in March 2025 forecasts that Brazil's Dengue outbreaks will refocus on the southern mountain area. The Brazilian Ministry of Health reported dengue cases among pregnant women reached 5,151 in the first six weeks of 2024, compared to 1,157 in the same period in 2023. In 2023, Brazil reported approximately 2.9 million patients, a 20% increase from the previous year, and Rio de Janeiro reported 22,959 dengue cases.

Dengue is hyperendemic in Colombia. It imposes a substantial economic burden on patients, caregivers, society, and the national health system. In 2025, Colombia's Huila Department declared a public health emergency.

According to the Health Surveillance Directorate of the Republic of Costa Rica, 1,076 dengue cases were reported in 2024. Costa Rica confirmed over 24,000 dengue cases in 2023, with the Huetar Caribe and Central Sur regions reporting the highest number of cases. As of August 4, 2023, all four dengue serotypes were registered.

In French Guyana, over 8,000 confirmed dengue cases have been reported since the beginning of 2024.

The U.S. CDC includes Mexico in its global Level 1 Dengue Travel Health Advisory. As of February 2025, Mexico has reported over 10,000 dengue cases. In 2024, Mexico confirmed about 549,000 dengue cases. A May 2024 model predicted that the percentage of municipalities affected by Dengue would rise from 55 to 91% in Mexico. Dengue was reported in 28 of 32 Mexican states in 2023, and transmission has been documented in Yucatan since 1979. All four DENV serotypes have been found in Mexico for decades. Between 1995 and 2008, constant circulation of DENV-3 was recorded in Mexico. Furthermore, notable increases in circulation were observed in 2022 (25%), 2023 (59%), and 2024 (86%).

In Nicaragua, 92,022 dengue cases were reported in 2024. A study published on January 10, 2025, demonstrates differences in dengue severity by serotype and immune status, emphasizing the critical need for a dengue vaccine with balanced effectiveness against all four serotypes, as existing vaccines show variable efficacy by serotype and serostatus.

DENV was reintroduced in Panama in 1993 after a 35-year absence of autochthonous transmission. All four serotypes were detected in Panama. As of April 2025, Panama reported over 4,800 Dengue cases. An analysis published in 2024 suggests that Panamanian strains were related to viruses from different regions of the Americas, suggesting a continuous exchange of viruses.

Paraguay's Ministry of Health confirmed that the DENV-3 subtype returned in 2025 after a nine-year absence. A study published in May 2025 suggests a high seroprevalence of DENV in Paraguayan blood donors. The high DENV seroprevalence reflects the impact of past Dengue outbreaks.

Peru issued an Alert in November 2024, notifying public and private health facilities of the increased risk of dengue infections. On November 23, 2024, a dengue vaccination program was launched in 16 districts of Loreto, Piura, Tumbes, and Ucayali regions.

On August 16, 2024, the Republic of Trinidad and Tobago confirmed 825 cases of Dengue Fever and eight (8) laboratory-confirmed deaths. The Caribbean reported over 62,000 dengue cases in 2023, a significant increase from 20,349 cases in 2022. Jamaica's Ministry of Health declared a dengue outbreak on September 23, 2023.

Dengue Outbreaks Australia 2025

In Australia, cases of locally acquired Dengue have historically been reported from most mainland Australian states. Dengue notifications have been reported monthly from 2019 to 2025. In January 2025, there were 261 Dengue case notifications. Queensland Health declared a Dengue outbreak centered in the Townsville City Local Government Area (TLGA) on February 19, 2025. As of March 25, 2025, 11 cases (9 confirmed and two probable) had been reported.

Dengue Outbreaks in Asia and the Pacific Islands

In 2025, the WHO confirmed that the Western Pacific Region continues to face a high burden of mosquito-borne arboviral diseases, particularly Dengue. In 2025, the U.S. CDC reported that countries in the WHO Western Pacific Region reported higher-than-usual dengue cases. Travelers visiting the following countries may be at increased risk: Bangladesh, Cambodia, Hong Kong, Indonesia, Fiji, Malaysia, Myanmar, Nepal, the Philippines, Samoa, Singapore, Sri Lanka, Tonga, and Thailand. The WHO publishes Dengue Situation Updates for the Western Pacific Region in 2025.

In 2025, the Cook Islands Ministry of Health declared a dengue fever outbreak in Rarotonga, following confirmation of seven dengue cases.

Fiji Ministry of Health & Medical Services confirmed one Dengue-related fatality on April 7, 2025. Between January and April 15, 2025, approximately 5,100 dengue cases were reported nationwide, with the Western Division leading with 2,077 cases. In 2014, the Fijian Government launched a cleanup campaign to combat the outbreak of dengue fever. Between November 2023 and April 2025, 1,721 dengue cases were reported in French Polynesia.

The Centre for Health Protection (CHP) in Hong Kong reported seven imported cases of dengue fever as of March 20, 2025. In 2024, 161 cases were imported (75 from Mainland China), and five local cases were reported. In 2023, 62 cases of DF were imported from abroad.

In September 2024, the WHO reported that dengue outbreaks in Indonesia (E000099) are at level 4. Dengue virus (DENV) infection is a significant cause of acute febrile illness in Indonesia, a DENV-endemic region that has experienced a 700-fold increase in incidence over the past 45 years. As of July 2024, 149,866 confirmed cases of Dengue and 884 deaths had been reported from 465 districts across 38 provinces in Indonesia.

Data published by the Dengue for Community Portal indicates that Taman Mawar-Sendang was a dengue hotspot in Malaysia in June 2025.

The French Department of Mayotte has confirmed 21 cases of Dengue since the beginning of 2025.

On April 9, 2025, the WHO intervened to prevent dengue outbreaks in Myanmar, distributing 4,500 rapid diagnostic test kits to frontline responders and health workers in displacement sites and remote villages.

The Republic of Nauru Ministry of Health has confirmed 379 dengue cases, and two fatalities were recorded on July 30, 2025.

As of June 20, 2025, the Republic of the Philippines reported about 100,000 dengue cases and a case fatality rate of 0.36%. In 2025, the Quezon City Government in the Philippines, through the City Health Department (QCHD), declared a dengue outbreak. From January to July 2025, the City Epidemiology and Surveillance Division of QCHD reported 5,702 dengue cases. In 2025, a total of 390 dengue cases, along with three deaths, were recorded in Antique. In 2024, the Republic of the Philippines Negros Occidental had 6,799 dengue cases and 22 dengue-related deaths in 2024.

The Independent State of Samoa announced on April 17, 2025, that the Ministry of Health is officially declaring a dengue fever outbreak. As of June 2, 2025, the Ministry of Health reported a total of 211 confirmed cases and one reported death. The majority of cases (76%) are from Upolu Island.

According to Sri Lanka's National Dengue Control Unit, 19,901 dengue cases were reported in the country in 2025.

During the first half of the 20th century, there were three island–wide dengue fever outbreaks in Taiwan. After almost forty years of dormancy, a DEN–2 outbreak occurred in 1981. Since 2006, Taiwan has faced dengue fever outbreaks of different scales every year. As of August 2025, a dengue cluster was reported in Kaohsiung's Gushan District.

Dengue Outbreaks in the Eastern Mediterranean Region

Dengue and severe dengue epidemics were first reported in the WHO's Eastern Mediterranean Region in 1998. Since then, outbreaks have occurred in all nine endemic countries: Afghanistan, Djibouti, Egypt, Oman, Pakistan, Saudi Arabia, Somalia, Sudan, and Yemen. On July 17, 2024, the WHO reported 12 autochthonous (local) cases of Dengue documented in Iran. In August 2024, dengue screening was launched at the Iranian border.

Dengue Outbreaks in Europe

In Europe, dengue viruses, transmitted by Aedes albopictus mosquitoes, are primarily associated with infections acquired in endemic countries. Local transmission remains rare, with only sporadic or small-scale outbreaks documented. As of December 2024, the European Centre for Disease Prevention and Control (ECDC) reported over 8,500 dengue-related deaths. In 2024, the ECDC reported locally acquired dengue cases in France, Germany, Italy, and Spain. Over 1,600 DENV infections in Germany occurred exclusively in travellers returning from dengue-endemic countries in 2024. In 2023, 130 locally acquired dengue cases were reported in the European Union and the European Economic Area (EU/EEA). The number of imported dengue cases in Europe increased from 1,572 in 2022 to approximately 4,900 in 2023.

On July 24, 2025, three confirmed cases of dengue fever were recorded in Budrio, Italy. As of July 15, 2025, Italian health authorities reported the first locally acquired case of Dengue of the year in Italy. The Italian National Public Health Authority reported 213 locally acquired dengue cases in 2024 and 82 cases in 2023. In Fano, a small coastal city in the Marche Region, Eurosurveillance reported 138 confirmed and 61 probable cases of DENV-2 as of October 28, 2024. Travel-related dengue cases have reached 472 in 2024. Non-travel-associated dengue cases have been reported in Italy since 2010, with a total of 10 cases.

On July 15, 2025, a second locally acquired case of Dengue was reported this year in Saint-Chamond, Auvergne-Rhône-Alpes, France. In 2024, France reported 82 locally transmitted cases of dengue fever and over 4,600 imported cases. Outbreaks were identified in the Provence-Alpes-Côte d'Azur, Occitanie, and Auvergne-Rhône-Alpes regions. In 2023, France reported nine dengue outbreaks, which resulted in 45 autochthonous infections. In 2022, France reported 65 locally acquired cases of Dengue.

In February 2025, the Autonomous Region of Madeira (Portugal) reported the results of entomological investigations confirming the presence of Dengue mosquitoes captured on Madeira. Two people were infected. The 2012 dengue outbreak affected approximately 1,000 residents.

Spain reported eight locally acquired dengue cases in the Camp de Tarragona area of the Catalonia region in 2024, and the Catalonia region reported three local cases in 2023.

Dengue Outbreaks in India

India has confirmed Dengue outbreaks for decades. In 2024, over 233,000 Dengue cases and 236 deaths were reported. As of 2024, dengue cases in India are on the rise, particularly in the states of Karnataka, Kerala, and Tamil Nadu. They generally peak in October. According to data from the National Centre for Vector-Borne Diseases Control Program, India reported 289,235 dengue cases and 485 related deaths in 2023. In the Democratic Socialist Republic of Sri Lanka, the co-circulation of multiple dengue virus genotypes was reported in October 2024 to be associated with an increase in cases.

Dengue United Kingdom 2025

The UK Health Security Agency (UKHSA) states that local dengue fever does not occur in the United Kingdom; however, it can be acquired by traveling to dengue-endemic areas. In 2024, 904 dengue cases were reported in returning travellers across England, Wales, and Northern Ireland, up from 631 in 2023. The most significant proportion of English cases (349) was reported in London. This data represents a 201% increase compared to the same period in 2023, which saw 157 cases. In 2024, India remained the most reported travel destination, with 179 cases, a 23% increase compared to 2023.

Dengue Virus-Carrying Mosquito

Mosquito bites cause more human suffering than any other organism. The spread of Dengue throughout the world can be directly attributed to the proliferation and adaptation of these mosquitoes. In the U.S., there are 176 species. A recent study published by the Royal Society indicates that dengue-carrying mosquitoes are expanding their range by an average of 6.5 meters of elevation and have moved polewards by 4.7 km annually.

Dengue Virus Infection Testing

The U.S. Centers for Disease Control and Prevention (CDC) published a Health Update (CDCHAN-00523) on March 18, 2025, highlighting the ongoing risk of Dengue virus infections and updates to testing recommendations in the United States. People with suspected Dengue virus infection should be tested with a real-time PCR, NS1 antigen test, or an IgM enzyme-linked immunosorbent assay antibody test at commercial labs or public health clinics.

Dengue Disease

Dengue is a disease caused by a virus transmitted through the bites of infected mosquitoes. It can take up to two weeks to develop, but the illness generally lasts less than a week. Without treatment, severe Dengue can become fatal. New research has identified pre-existing anti-DENV IgG antibodies as the cause of the increased duration of Dengue upon second exposure.

Severe Dengue

Approximately 5% of Dengue cases can progress rapidly to Severe Dengue, which may involve hypovolemic shock, gastrointestinal or vaginal bleeding requiring transfusion, and end-organ impairment. Furthermore, women infected with Dengue during pregnancy can pass the virus to their fetuses. Promptly initiating intensive supportive therapy can reduce the risk of death among patients with severe Dengue. The extent and duration of viremia are often correlated with the severity of clinical disease. A study published in October 2024 concluded that secondary dengue infections with different dengue virus serotypes have been linked to an increased risk of Severe Dengue after two years.

Dengue Infections Cause Cardiovascular Complications

Published on April 18, 2025, this review discusses the cardiovascular manifestations of Dengue and their management, explores the proposed pathogenesis, and concludes with a discussion of potential future research directions.

Dengue Viruses

There are four Dengue Viruses. A study published in October 2024 concluded that the co-circulation of multiple genotypes is associated with an increase in severe cases, highlighting the importance of continuous surveillance.

Dengue Virus Blood Transfusion-Transmission

Emerging evidence published in November 2024 suggests a potentially concerning route of blood transfusion-transmitted dengue virus (TT-DENV), which poses a critical threat, especially in endemic countries like Brazil. In May 2024, a RESEARCH ARTICLE found that dengue virus transmission was a risk in blood donation in Thailand. In March 2016, Transfusion-Transmitted Dengue and Associated Clinical Symptoms During the 2012 Epidemic in Brazil was published.

Dengue Infection Immune-Mediated Enhancement

In this study, published on October 31, 2024, researchers demonstrate that the expression of a DENV-specific B cell receptor (BCR) renders cells highly susceptible to DENV infection, with the infection-enhancing activity of the membrane-restricted BCR correlating with the antibody-dependent enhancement (ADE) potential of the IgG version of the antibody. In addition, they observed that the frequency of DENV-infectible B cells increases in previously flavivirus-naïve volunteers after a primary DENV infection. These findings suggest that BCR-dependent infection of B cells is a novel mechanism for immune-mediated enhancement of DENV infection. This observation indicates that BCR-dependent infection of DENV-specific B cells may be a complementary mechanism for immune-mediated enhancement of DENV infection, expanding upon existing models of antibody-dependent enhancement.

Dengue Outbreak Discrepancy Research

In October 2024, a study published by The Lancet Infectious Diseases provided novel insights into serotype-specific epidemiological patterns and disease outcomes of primadengue virus (rDENV)ENV infections by revealing the hidden contribution of inapparent infections. This indicates that case surveillance skews the perceived epidemiological footprint of Dengue's four viruses. On October 25, 2024, these researchers wrote, 'While inapparent infections are often overlooked and do not require immediate medical attention, we have assumed that they account for up to 88% of all dengue virus (DENV) transmission events. A study published in May 2024 revealed substantial discrepancies between estimates and reported numbers of dengue cases. A study published in the journal Nature on January 20 revealed variations in antibody composition that contribute to the miscounting of primary and secondary infections.

Dengue Virus in Pregnant Women

The CDC confirms that a pregnant woman already infected with Dengue can pass the virus to her child during pregnancy, and there has been one documented report of Dengue spread through breast milk. A study published in the American Economic Journal: Applied Economics in April 2024 confirmed robust evidence for the adverse effect of dengue infections on birth weight and documented increases in children's hospitalizations and medical expenditures for up to three years after birth.

Dengue and Zika Virus

A study published in the journal Science Translational Medicine on May 29, 2024, found that primary ZIKV infection increased the risk of disease caused by DENV3 and DENV4 but not DENV1. This finding was also observed for tertiary infections in individuals previously infected with DENV and ZIKV, but not in those previously infected with ZI alone.

Dengue Vaccines

Information on dengue vaccines (Qdenga), vaccine candidates, and clinical trials in 2025 can be found at Vax-Before-Travel.

21 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Wednesday, September 17, 2025 - 04:55

Description:

Dengue outbreaks in Africa, Asia, Brazil, California, Caribbean, China, Costa Rica, Florida, France, India, Italy, Jamaica, Mexico, Spain, Thailand.

Vaccine:

QDENGA Dengue Vaccine

CodaVax RSV Vaccine

CodaVax™ RSV Vaccine May 2023

CodaVax™-RSV intranasal, live-attenuated vaccine candidate has the potential to induce innate immunity and durable local and systemic immunity.

Codagenix Inc. is utilizing codon-deoptimized live vaccine candidates to deliver all the benefits of live vaccines on short timelines while offering unparalleled genetic stability. Codagenix's "death by a thousand cuts" approach takes the genetic sequence of the wild-type target and uses an AI-aided algorithm to compute the hundreds or thousands of sites where codons can be modified to produce the same amino acid sequence with lower translational efficiency. This process yields a small, testable number of candidate viral genomes that produce all the same proteins as the wild type but with far less virulence, exponentially accelerating timelines for candidate development. In addition, unlike previous live-attenuated RSV vaccine candidates, CodaVax-RSV is highly stable due to genetic edits that prevent wild-type reversion.

On May 10, 2023, Codagenix announced that it initiated dosing in a pediatric Phase 1 study evaluating the CodaVax™-RSV vaccine as an age de-escalation, dose-escalation design specifically evaluating safety and immunogenicity in the 6-month to 5-year-old population. The trial is being conducted under U.S. FDA IND and Fast Track designations.

New York-based Codagenix is a clinical-stage biotechnology company leading a new era of live vaccines and viral therapeutics.

CodaVax Indication

CodaVax is indicated to prevent (RSV) infections in infants and adults. RSV is a leading cause of hospitalization due to acute lower respiratory infection, particularly in infants, young children, and elderly adults.

CodaVax News 2023

May 10, 2023 - "Codagenix is focused on providing an effective prophylactic vaccine for infants and toddlers six months to 5 years old who, based on the recent data, may be at higher risk for hospitalization following infection despite recent innovations in other RSV vaccines for the elderly that are under review," said J. Robert Coleman, Ph.D., Co-founder and Chief Executive Officer of Codagenix.

November 2, 2022 - The US FDA has granted Codagenix Fast Track Designation for CodaVax-RSV, an intranasal RSV vaccine candidate.

June 1, 2022 - Codagenix Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CodaVaxTM-RSV.

CodaVax Clinical Trials

CodaVax has completed a phase 1 clinical trial and will begin recruiting for another phase 1 trial. The first phase 1 clinical trial has been completed: Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers. This trial began on July 10, 2020, enrolling 36 healthy adult volunteers. The participants received two doses, 28 days apart. The vaccine was administered as nose drops.

The second phase 1 study - CodaVax-RSV in Seropositive and Seronegative Children, was Last Updated on April 20, 2023.

0 min read

Manufacturer:

Codagenix, Inc.

Reviewer:

Robert Carlson, MD

Vaccine:

CodaVax RSV Vaccine

Availability:

N/A

Generic:

RSV Nasal Vaccine

Drug Class:

Intranasal

Clinical Trial Phase I:

Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers

Condition:

Respiratory Syncytial Virus (RSV)

Last Reviewed:

Wednesday, May 10, 2023 - 08:10

Brand:

CodaVax

Status:

Candidate

Manufacturer Country ID:

Ebola Outbreaks

Ebola Outbreaks September 2025

The initial Zaire Ebolavirus disease case was confirmed in 1976 in a village near the Ebola River in Africa, according to the World Health Organization (WHO). A study published on August 18, 2023, says the origins of Ebola remain enigmatic. Recent data suggest that some Ebola virus (EBOV) outbreaks may originate from the human-to-human transmission of prior Ebola virus disease (EBVD) outbreak strains, rather than spillover. Orthoebolaviruses are a group of four viruses that cause Ebola disease. As of 2025, more than 30 EBVD outbreaks have been reported. The WHO posted a Chronology of EBOV outbreaks.

Zaire Ebolavirus Outbreaks

Africa experienced Ebola virus outbreaks in the Democratic Republic of the Congo (DRC), formerly known as Zaire, in 2014, 2016, 2018, and 2022. Over 29,000 people were infected, and more than 11,000 died. On September 4, 2025, the DRC declared an outbreak of Ebola virus disease in Kasai Province, where 28 suspected cases and 15 deaths occurred, including four health workers. There have been 15 outbreaks in the DRC since the disease was first identified in 1976.

Sudan Ebolavirus Outbreak

The Uganda Ministry of Health declared its eighth Sudan Ebolavirus Disease (SVD) outbreak in January 2025. As of April 26, 2025, Uganda's second SVD outbreak in three years was declared over by the WHO Africa. During this SVD outbreak, 14 cases and four deaths occurred.

The U.S. CDC reissued a Travel Health Advisory Level 2, Practice Enhanced Precautions notice on March 12, 2025, regarding Uganda's current SVD outbreak. The CDC previously issued Health Alert Network Health Advisory CDCHAN-00477 on October 6, 2022, and CDCHAN-00480 on November 7, 2022. Since October 2022, all U.S.-bound passengers from Uganda have been routed to designated airports for enhanced Ebola screening. Traveler screening at Ugandan entry points remains active in 2025, with 25,364 travelers screened for SVD as of March 2, 2025.

The UKHSA issued a public health message in November 2022 regarding the SVD outbreak in Uganda. All workers returning to the UK from areas affected by SUDV should undergo a risk assessment. On November 1, 2022, the WHO advised against imposing any travel and/or trade restrictions on Uganda based on the available information regarding the current SUDV outbreak.

On May 8, 2023, North Kivu, DRC, confirmed a positive case of SUDV.

Ebola in the United States

The U.S. CDC updated its Ebola Outbreak History on August 31, 2023. The CDC says that 11 people were treated for EVD in the U.S. during Africa's 2014-2016 epidemic. On September 30, 2014, the CDC confirmed the first travel-associated case of Zaire EVD was diagnosed in the U.S. in a traveler from West Africa to Dallas, Texas. The patient (the index case) died on October 8, 2014. Two healthcare workers who cared for him tested positive for EVD, and both recovered. On October 23, 2014, a medical aid worker who had volunteered in Guinea was hospitalized in New York City, NY, and was diagnosed with EVD. The aid worker recovered, and seven others were cared for in West Africa. Six of these EVD patients recovered; one died, reported the CDC.

Ebola Vaccines

As of 2025, Ebola vaccines are not commercially available in the United States. Ebola vaccine information is posted at the Vax-Before-Travel link.

Ebola Therapy

The U.S. Food and Drug Administration authorized Ebanga for intravenous injections on December 21, 2020.

Ebola Prevention and Control Guidelines

In August 2024, the WHO published updated research priorities for infection prevention and control in healthcare settings. Key recommendations are summarized in The BMJ. On December 18, 2023, Texas Biomed announced findings published in the Journal of Infectious Diseases (Sept. 2023) indicating that the Ebola virus creates and uses intercellular tunnels to move from cell to cell and evade treatments. "Our findings suggest that the virus can create its hiding place, hide, and then move to new cells and replicate," says Olena Shtanko, Ph.D., an Assistant Professor at Texas Biomed and senior author.

Ebolavirus Diagnostic Tests

A novel patch-based ebolavirus diagnostic test was announced in August 2023.

Ebolavirus Disease

The Ebolavirus family Filoviridae includes three genera: Cuevavirus, Marburgvirus, and Ebolavirus. Within the genus Ebolavirus, six species have been identified: Sudan, Zaire, Bundibugyo, Reston, Taï Forest, and Bombali. Ebola viruses (EBOV) assemble into filamentous virions whose shape and stability are determined by the matrix viral protein 40 (VP40). The pH-driven structural remodeling of the VP40 matrix acts as a molecular switch coupling viral matrix uncoating to membrane fusion during EBOV entry. According to the WHO, EVD is transmitted to people from wild animals and spread through human-to-human transmission, with case fatality rates varying from 25% to 90%. The time from infection with the Ebola virus to symptom onset, including fever, fatigue, muscle pain, headache, and sore throat, can range from 2 to 21 days.

5 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Thursday, September 4, 2025 - 11:50

Description:

Zaire and Sudan ebolavirus outbreaks began in 1976 and continue in Africa.

Condition:

Ebola

Polio Vaccines

Polio Vaccines December 2025

As of 2025, two types of poliomyelitis vaccines are in use, according to the U.S. Centers for Disease Control and Prevention (CDC), the European Medicines Agency (EMA), the United Kingdom's NHS, and the World Health Organization (WHO). The inactivated (killed) polio vaccine (IPV) was developed by Dr. Jonas Salk in 1955 and has been offered in the U.S. since 2000. IPVs produce antibodies in the blood that target all three types of poliovirus, thereby preventing the virus from spreading. The live attenuated (weakened) oral polio vaccine (OPV) was developed by Dr. Albert Sabin in 1961.

The WHO's Strategic Advisory Group of Experts on immunization (SAGE) recommended that fractional doses of Sabin-based IPV be used in the same way as fractional doses of Salk-based IPV. As of December 2025, the SAGE also supported the broader rollout of the novel oral polio vaccine type 2 (nOPV2) to help stop persistent outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2).

In September 2024, the SAGE expressed support for planning the eventual global cessation of use of bivalent oral poliovirus vaccines (bOPV). The Global OPV Stockpile Strategy for 2022-2026 was published in 2023.

As of 2025, the Global Polio Eradication Initiative (GPEI) states that the OPV contains a weakened strain of the poliovirus that has evolved over time and now behaves similarly to wild-type polio infections. In addition, OPV can mutate sufficiently to regain virulence and lead to vaccine-derived poliovirus, which can paralyze an unvaccinated person. OPVs not only eradicated serotype two but also reduced mortality among young children. The OPV confers cross-protection against non-polio enteroviruses, respiratory viruses, and herpes viruses due to the early activation of CD4+ and CD8+ T cells via pattern-recognition receptors, the reconfiguration of innate immune cells through epigenetic manipulation, and cross-reaction between B cells and T cells, among other mechanisms.

Polio Vaccinations U.S. CDC

The IPV vaccine has been available in the U.S. since 2000. As of August 2025, the CDC says the IPV can reduce the amount of poliovirus people shed, but can't stop all virus transmission. The CDC published a poliovirus vaccine update, recommending that children receive four doses of any combination of IPV and trivalent oral polio vaccine (tOPV) or a primary series of at least three doses of IPV or tOPV. The OPV is not offered in the U.S. Since 1961, the FDA has required testing to ensure that polio vaccines used in the United States are free of SV40 contamination.

Polio Vaccine Effectiveness

Estimates of vaccine effectiveness against paralytic polio range from 36% to 89% for a single dose, and IPV vaccination appears to reduce the mean amount of shed poliovirus by 63% to 91%. Research indicates no significant differences in the odds of poliovirus shedding between individuals with IPV and those who are unvaccinated. A U.S. CDC-funded study published by The Lancet on May 10, 2023, concluded that co-administration of nOPV2 and bOPV interfered with immunogenicity for poliovirus type 2 but not for types 1 and 3. The blunted nOPV2 immunogenicity we observed would be a significant drawback of co-administration as a vaccination strategy.

Polio Vaccine Booster Dose

On December 4, 2023, the U.S. CDC MMWR published updated recommendations for the use of IPV for adults known to be unvaccinated or incompletely vaccinated. States that fully vaccinated adults are at increased risk for poliovirus exposure may receive a single lifetime booster dose of IPV. The CDC's Advisory Committee on Immunization Practices (ACIP), led by Oliver Brooks, MD, FAAP, reviewed poliovirus, polio vaccination, and polio epidemiology on June 21, 2023. The ACIP's Proposed Language: Adults who have received a primary series of tOPV or IPV in any combination and are at increased risk of poliovirus exposure may receive another (booster) dose of IPV. Available data do not indicate the need for more than one lifetime booster dose for adults with IPV. Sarah Kidd, MD, MPH, led the ACIP presentation on Adult Polio Vaccination: Recommendations for Unvaccinated and Incompletely Vaccinated Adults, as well as Recommendations for Booster Doses of IPV.

Polio Vaccines 2025

IMARC Group's new report indicates that the poliomyelitis vaccine market is expected to exhibit a CAGR of 5.04% from 2024 to 2034.

PT Bio Farma and Biological E. Limited produce the WHO-prequalified nOPV2 vaccine. As of July 2024, approximately one billion doses have been administered in more than 35 countries worldwide.

The Imovax Polio® (IPOL® IPV) vaccine is indicated for active immunization of infants (as young as six weeks), children, and adults to prevent poliomyelitis caused by poliovirus types 1, 2, and 3. The IPV protects against both wild-type polio and this weakened poliovirus strain. On February 28, 2024, the CDC vaccine committee reviewed the Clinical Considerations for Children Who Received a Fractional Dose of Inactivated Poliovaccine. Refer to the ACIP IPV catch-up vaccine table for details and age groups.

Kinrix is indicated as the fifth dose in the IPV series for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children ages 4 through 6.

Pediarix is a vaccine for active immunization against diphtheria, tetanus, pertussis, hepatitis B, and infection caused by all known subtypes of the hepatitis B virus, as well as poliomyelitis.

Pentacel is a multi-vaccine that contains diphtheria, tetanus toxoids, and acellular pertussis adsorbed, as well as inactivated poliovirus (DTaP-IPV), which is common, and an ActHIBHIB vaccine component.

Quadracel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis.

SanShantha Biotechnics manufactures Sanofi's IMOVAX-Polio IPV vaccine in Hyderabad and has been used in over 100 countries for more than 40 years. ShanIPV IPV is an inactivated polio vaccine developed by Shantha Biotechnics. It received WHO prequalification status and was produced by Sanofi in Hyderabad, India, until December 2023. Sanofi Pasteur became the first contributor to IPV in India in March 2014.

Sabin IPV, an inactivated vaccine produced by SINOVAC Biotech Ltd., is indicated for preventing the wild poliovirus and was WHO-prequalified in June 2022.

LGChem (Eupolio) is the first attenuated Sabin-IPV to obtain WHO prequalification. The main advantage is a lower biosafety risk.

SINOVAC's sIPV polio vaccine was WHO-prequalified in June 2022 to prevent poliomyelitis caused by infection with types I, II, and III polioviruses. sIPV is available for purchase by United Nations agencies.

Bio Farma bOPV Bivalent Type 1 & 3 Oral Poliomyelitis Vaccine.

Bilthoven Biologicals produces an inactivated polio vaccine and plans to collaborate with Bharat Bio to develop an OPVtech.

Codagenix Inc. received funding to apply its proprietary synthetic biology technology to fortify nOPV strains against recombination with other enteroviruses, thereby further reducing the risk of emergence of potentially neurovirulent vaccine-derived polioviruses.

Novel Oral Polio Vaccine

Since the nOPV2 vaccine launched in Africa, approximately 2 billion doses have been administered in more than 29 countries. The U.S. CDC confirmed the nOPV2 vaccine is more genetically stable and less likely to be associated with the emergence of cVDPV2.

Bio Farma manufactures novel OPVs against polio types 1 and 3, and they are undergoing several clinical studies sponsored by PATH. A study published in The Lancet Infectious Diseases on August 13, 2025, showed results of a phase 1 randomized controlled trial that the novel live attenuated type 1 and 3 oral polio vaccines (nOPV1 and nOPV3) have a favorable safety profile and produce a comparable immune response and viral-shedding profile as the homotypic monovalent (single-strain) Sabin-strain oral vaccines (mOPVs).

Polio Vaccination United Kingdom

The UK Health Security Agency (UKHSA) confirmed that an IPV Booster campaign was launched in London on September 29, 2022, targeting children aged 1 in 2022. The polio vaccine is part of the NHS childhood vaccination schedule.

Polio Vaccine Fractional Dose

In 2016, the World Health Organization (WHO) announced a global shortage of IPV, specifically in India. In response, WHO's Strategic Advisory Group of Experts on Immunization (SAGE) recommended a strategic shift to fractional-dose inactivated poliovirus vaccine (fIPV), a smaller dose of the same vaccine equivalent to 1/5 of a standard dose, according to the GPEI. Studies show that two doses of fractional-dose IPV administered intradermally produce a more robust immune response than a single full-dose Dose.

Polio Vaccine Price

The U.S. CDC confirms that the Vaccines For Children program is federally funded and provides IPV vaccines and medicines at no cost to children who might not otherwise be vaccinated due to inability to pay. The U.S. CDC Vaccine Price List was updated in 2023. This UNICEF table provides an overview. For people in the U.S. without health insurance, a polio booster typically costs around $100. For example, pharmacies may charge about $100 for an IPV polio booster shot.

Polio Vaccine Misinformation Management

Yale Institute for Global Health and The Public Good Projects partnered in 2020 to create the Vaccine Misinformation Management Field Guide. This guide aims to help organizations address the global infodemic by developing strategic, well-coordinated national action plans to counter vaccine misinformation and build demand for vaccinations rapidly, informed by social listening. The Digital Community Engagement (DCE) initiative recruits digital volunteers through an interactive online platform, uInfluence, to promote accurate information on polio and vaccines. In 2022, over 5 million online social listening results were analyzed from 41 countries in more than 100 languages.

Polio Vaccine Transition

In 2016, the CDC announced that to address the risks posed by type 2 circulating vaccine-derived polioviruses, the type 2 component of the OPV was withdrawn through a switch from the tOPV to the bOPV, which contains only attenuated viruses of types 1 and 3. However, the bOPV vaccine does not offer immunity against serotype 2. This change reduced the risk of tOPV seeding new cVDPV2 outbreaks in the U.S.

The GPEI reports that, before April 2016, the trivalent oral poliovirus vaccine (tOPV), which contains types 1, 2, and 3, was the predominant vaccine used for routine immunization against poliovirus. Before the development of tOPV, monovalent OPVs (mOPV2) were developed in the early 1950s but were discontinued upon the adoption of tOPV. Following April 2016, the tOPV was replaced with the bivalent oral poliovirus vaccine (bOPV). As of February 2023, the tOPV remains used with children in countries such as Somalia. On August 9, 2023, the Strategy Committee of the GPEI announced that it had commissioned a formal evaluation of the 2016 global withdrawal of Sabin poliovirus type 2 (OPV2), the switch from tOPV to bOPV. The review aims to generate critical lessons learned from the OPV2 withdrawal to guide the direction of the GPEI, including future OPV withdrawal efforts. The finalization and publication of the evaluation are planned for mid-2024. On May 12, 2023, the CDC reported that from January to 021 March 31, 2023, GPEI supported 48 countries, during which approximately 988 million bOPV, 616,000 IPV, 960,000 fractional IPV, 90 million mOPV2, 595 million nOPV2, and 100 million tOPV doses were administered. The 6th Transition Independent Monitoring Board report was published on August 2, 2023, evaluating the progress and challenges of the polio transition process and recommending strengthening work at the global, regional, and country levels.

Poliovirus Outbreaks

The latest news on polio outbreaks is posted by Vax-Before-Travel in 2025.

10 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Saturday, December 13, 2025 - 10:55

Description:

Polio vaccines are available globally in 2025

Condition:

Polio